November 09, 2010

A former vice president and associate general counsel at GlaxoSmithKline was indicted Monday in Maryland on obstruction, false statements and other charges for her alleged criminal interference with a federal regulatory drug investigation in 2002.

Lauren C. Stevens, a member of the North Carolina bar since 1985 who has since retired from GlaxoSmithKline, was charged in Maryland federal district court with obstructing an official proceeding, concealing and falsifying documents and making false statements to the U.S. Food and Drug Administration.

Justice Department officials, who announced the indictment today, said the FDA in October 2002 asked for information about GlaxoSmithKline’s promotion of a prescription drug as part of a probe into the off-label promotion of the drug for weight loss and the treatment of obesity. The indictment alleges Stevens, who is represented by Ropes & Gray and Steptoe & Johnson, knew GlaxoSmithKline promoted the drug for unapproved uses.

DOJ did not identify the name of the drug in court papers, and the department said the “major pharmaceutical company”—which DOJ also did not identify in court papers—has not been charged with a crime. A GlaxoSmithKline spokeswoman declined to comment.

“Where the facts and law allow, the Justice Department will pursue individuals responsible for illegal conduct just as vigorously as we pursue corporations,” Assistant Attorney General Tony West of the Civil Division said in a statement today. “Criminal charges are appropriate when false statements such as those alleged here are made to the FDA.”

Stevens, according to charging documents, knew GlaxoSmithKline paid physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. One doctor, in Michigan, spoke at 488 promotional events GlaxoSmithKline sponsored in 2001-2002, according to court papers.

The indictment alleges Stevens did not provide slide sets that physicians used to promote the drug even though she said she promised to obtain and turn over the information to federal regulators. Stevens, according to the indictment, prepared a legal memorandum assessing the benefits and drawbacks of producing the slides to the FDA. For more on the case, including a copy of the indictment, click here for a report in Corporate Counsel.

A lawyer for Stevens, Ropes & Gray partner Brien O'Connor in Boston, said Stevens is not guilty of obstruction and making false statements.

"Everything she did in this case was consistent with ethical lawyering and the advice provided her by a nationally prominent law firm retained by her employer specifically because of its experience in working with FDA," O'Connor said. "She looks forward to the day when a judge and jury can hear the true facts in this case, which will show that she has done absolutely nothing wrong."